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NCT Number: NCT05715411

Assessment of Light Therapy in Insomnia Disorder

Sleep disorders represent a major public health issue and the leader in these disorders is insomnia with 10 to 15% of subjects in the general population reporting symptoms of insomnia with a daytime impact. In addition to being very common, insomnia leads to an increase in morbidity and mortality and weighs on healthcare systems worldwide. Despite this public health context, insomnia is underdiagnosed and rarely treated. Hypnotics have proven efficacy but with a risk of dependence and pharmacotolerance which appears within a few weeks. Cognitive behavioral therapy (CBT) has a good level of evidence and is now a benchmark treatment for the management of insomnia. Unfortunately, not all patients adhere to or respond to these procedures, which cannot be implemented for many of them either. There is therefore a need to identify other alternative therapeutic strategies, and we believe that exposure to light is a promising treatment.

In this perspective, it seems interesting to assess the effect of the propensity to fall asleep with an exposure to light therapy in patients suffering from insomnia.

In order to be in optimal ecological conditions, we want to use a portable light therapy device which allows easy, acceptable and ambulatory exposure.

If the lighttherapy is confirmed in insomnia under ecological conditions, this would make it possible to propose a new non-drug treatment, easy to access and on a large scale

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Location status: Recruiting

Location contact

Patrice BOURGIN, MD

CONTACT

[email protected]

03 88 11 64 30

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient aged 30 to 60 years
  • Insomnia disorders (ICSD-3) with sleep latency >30min - 3 times a week
  • Patient able to understand the objectives and risks associated with the research and to give informed dated and signed consent
  • Patient affiliated to a social health insurance scheme
  • For women of childbearing age, effective contraceptive measure for the duration of the research (hormonal contraception, IUD).

Exclusion criteria

  • - Shift work in the year preceding inclusion
  • Trans meridian travel (> 2 time zones) in the month preceding inclusion
  • Patient in exclusion period determined by a previous or ongoing study
  • Impossibility of giving the patient informed information (emergency patient, difficulty understanding the patient)
  • Patient under judicial protection
  • Patient under guardianship or curatorship
  • For a woman of childbearing age: ongoing pregnancy or breastfeeding
  • Drug treatment which can disturb sleep or the measurement of DLMO: corticosteroids by general route, beta-blockers in the evening, exogenous melatonin.
  • Phase delay syndrome defined according to the criteria of the international classification of ICSD-3
  • Restless legs syndrome with IRLS score> 20
  • Other psychiatric disorders or addictive disorder (screening with the MINI structured interview)
  • Other medical conditions not stabilized (detected by clinical interview), only the diseases appearing in the following list will constitute a criterion of non-inclusion:
  • Chronic allergies
  • Neurological disorders
  • cardiovascular, respiratory, gastrointestinal, hematopoietic, visual diseases
  • diseases of the immune system
  • kidney and urinary tract diseases
  • endocrine and metabolic diseases
  • infectious diseases
  • epilepsy

Treatment and study plan

Placebo with light therapy glasses

Other

Placebo

light therapy with light therapy glasses

Other

light therapy

Primary outcomes

  1. Change Sleep latency

    Time frame: At day 0 and Day 44

    Actimetry is used to compare the sleep latency

Secondary outcomes

  1. Change Daytime sleepiness

    Time frame: At day 0 and Day 90

    Epworth Scale is used to compare the sleepiness in baseline to completion of the procedure and three month after intervention

  2. Change Daytime sleepiness

    Time frame: At day 0 and Day 90

    Karolinska Sleepiness Scale is used to compare the sleepiness in baseline to completion of the procedure and three month after intervention

  3. Change Circadian rythms

    Time frame: At day 0 and Day 90

    Circadian markers melatonin is measured in baseline, completion of the procedure and three month after intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Patrice BOURGIN, MD

CONTACT

[email protected]

03 88 11 64 30 ext. 0033

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: InsomLum

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 8, 2023
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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